GNH USA

Europe — EMA

Grazax

Grazax sublingual tablet (225 µg Phleum pratense) is a prescription allergy immunotherapy for seasonal grass‑pollen rhinitis and rhinoconjunctivitis in the EU.

Phleum Pratense (225)

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What is Phleum Pratense (225)?

Grazax is a sublingual tablet containing 225 µg of standardized Phleum pratense (Timothy grass) allergen extract. It is prescribed as an allergen immunotherapy for patients with seasonal allergic rhinitis or rhinoconjunctivitis caused by grass pollen. The medication is administered under the tongue and is available by prescription in the European Union.

What is Phleum Pratense (225) used for?

Grazax is indicated for the treatment of grass‑pollen allergy symptoms and to modify the underlying allergic response. It is used as a disease‑modifying therapy rather than a rescue medication.

- Seasonal allergic rhinitis caused by Timothy grass pollen. - Allergic rhinoconjunctivitis due to grass pollen exposure. - Long‑term immunotherapy to reduce the need for symptomatic antihistamines. - Prevention of symptom escalation during peak grass season. - Adjunct to environmental control measures for grass pollen allergy.

What are the side effects of Phleum Pratense (225)?

Side effects of Grazax are generally mild and related to local exposure of the oral mucosa, but rare systemic reactions can occur.

Common: - Mild oral itching or tingling. - Sore throat or mild throat irritation. - Transient mouth or tongue swelling. - Mild gastrointestinal discomfort. - Nasal congestion or runny nose. - Headache.

Serious: - Anaphylaxis or severe systemic allergic reaction. - Persistent or worsening throat swelling that interferes with breathing. - Severe urticaria (hives) beyond the oral cavity. - Angioedema involving the face or lips. - Bronchospasm or wheezing. - Cardiovascular symptoms such as hypotension.

What precautions apply to Phleum Pratense (225)?

Before starting Grazax, patients should consider several safety factors and follow medical guidance.

- Confirm diagnosis of grass‑pollen allergy with appropriate testing. - Do not use if you have a history of severe anaphylaxis to grass pollen. - Discuss any current immunotherapy, biologic agents, or recent vaccinations with your clinician. - Use caution if you have uncontrolled asthma or chronic respiratory disease. - Pregnant or breastfeeding individuals should consult a healthcare professional before use. - Keep the tablet in the original container, out of reach of children. - Discontinue use and seek medical attention if severe side effects develop.

What does Phleum Pratense (225) interact with?

Grazax may interact with other medications or substances that affect immune response or increase allergy risk.

Avoid: - Concurrent use of other allergen immunotherapy products without medical supervision. - Systemic corticosteroids taken within two weeks of initiating therapy.

Use with caution: - Beta‑blockers, which may mask symptoms of anaphylaxis. - ACE inhibitors, which can exacerbate angioedema. - Antihistamines, as they may reduce local tolerability but do not affect efficacy. - Live vaccines, which should be administered at least four weeks before starting Grazax. - Immunosuppressive agents, which could alter the immunologic response to the tablet.

Frequently asked questions

What is the active ingredient in Grazax and how is it standardized?+
Grazax contains a standardized extract of Phleum pratense (Timothy grass) allergen, delivering 225 µg of the allergen per tablet. Standardization ensures consistent potency across batches.
How does sublingual immunotherapy with Grazax work to reduce allergy symptoms?+
Repeated sublingual exposure to the grass pollen allergen induces immune tolerance by shifting the response from IgE‑mediated hypersensitivity toward IgG4 production and regulatory T‑cell activation, thereby decreasing symptom severity over time.
Who is an appropriate candidate for Grazax therapy?+
Patients with confirmed seasonal allergic rhinitis or rhinoconjunctivitis caused by grass pollen, who seek a disease‑modifying approach and have no history of severe anaphylaxis to grass, are typical candidates.
When should Grazax be started relative to the grass pollen season?+
Grazax is usually initiated at least 8–12 weeks before the expected start of the grass pollen season to allow the immune system to develop tolerance before exposure peaks.
What is the recommended administration method for Grazax tablets?+
The tablet is placed under the tongue, allowed to dissolve completely, and then the patient should avoid eating or drinking for at least 30 minutes to ensure adequate absorption.
Can Grazax be used together with antihistamines or nasal steroids?+
Yes, symptomatic medications such as antihistamines or intranasal steroids can be used alongside Grazax, as they do not interfere with the immunotherapy’s mechanism.
What are the most common side effects experienced with Grazax?+
Typical side effects include mild oral itching, throat irritation, transient swelling of the mouth or tongue, mild gastrointestinal discomfort, nasal congestion, and headache.
What signs indicate a serious reaction that requires immediate medical attention?+
Symptoms such as difficulty breathing, severe throat swelling, hives beyond the oral area, wheezing, hypotension, or any signs of anaphylaxis should prompt urgent medical care.
Is Grazax safe for use during pregnancy or breastfeeding?+
The safety of Grazax during pregnancy or lactation has not been established; patients should discuss potential risks with their healthcare provider before starting therapy.
How long does a typical course of Grazax treatment last?+
A full course generally spans three consecutive grass pollen seasons, with daily administration throughout each season to achieve sustained clinical benefit.
What should be done if a dose of Grazax is missed?+
If a dose is missed, the patient should take the missed tablet as soon as they remember, unless it is close to the time of the next scheduled dose. In that case, skip the missed dose and resume the regular schedule.
Are there any special storage requirements for Grazax tablets?+
Grazax should be stored at room temperature, protected from moisture and direct sunlight, and kept out of reach of children.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Phleum Pratense (225)
Route
Sublingual Use
Manufacturer
Alk-Abello A/S
Origin
EU

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